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The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF 50 Y49 091 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
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| SPF 50 X15 158 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
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| SPF 50 X15 160 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
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| SPF 50 X57 162 | Experimental | Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPF 50 Y49 091 (BAY 987516) | Drug | 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective discomfort | Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article | up to 10 days |
| Objective lacrimation | Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow | up to 10 days |
| Objective conjunctival inflammation | Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids | up to 10 days |
| Objective cornea and iris inflammation | Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding or pitting of cornea and/or thickening of the iris | up to 10 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Petersburg | Florida | 33714 | United States |
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| SPF 50 X15 158 (BAY 987516) | Drug | 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. |
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| SPF 50 X15 160 (BAY 987516) | Drug | 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. |
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| SPF 50 X57 162 (BAY 987516) | Drug | 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. |
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| J & J baby shampoo, X46 046 (control) | Other | 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. |
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